基于高效液相色谱指纹图谱和量值传递的化痰解郁合剂质量研究

Quality Study of Huatan Jieyu Mixture Based on HPLC Fingerprint and Quality Value Transmitting

目的为评价化痰解郁合剂的质量提供参考。方法采用高效液相色谱(HPLC)法建立化痰解郁合剂中试复方煎液的HPLC指纹图谱,采用中药色谱指纹图谱相似度评价系统(2012版)进行相似度评价,并进行聚类分析;测定各样品中辛弗林、芍药苷、橙皮苷和固形物的含量,并计算前三者的转移率。结果10批复方煎液的HPLC图谱中共确定20个共有峰,指认出其中9种成分,包括辛弗林、芍药苷、橙皮苷等;复方煎液、浓缩液和离心液与小试样品建立的HPLC指纹图谱的相似度分别为0.936,0.886,0.865;聚类分析结果显示,3批复方煎液与10批小试样品中的8批可聚为一类;辛弗林、芍药苷和橙皮苷的转移率分别为80.13%,51.36%,9.97%;固形物在复方煎液、浓缩液、离心液及中试产品中的平均含量分别为7.46,148.03,137.53,141.60 g/L。结论所建立的方法快速、简单、可行,重复性、稳定性良好,适用于化痰解郁合剂中试复方煎液、浓缩液、离心液及中试产品量值传递规律的相关性考察,可用于其质量控制。

Objective To provide a reference for evaluating the quality of Huatan Jieyu Mixture.Methods High-performance liquid chromatography(HPLC)method was used to establish the HPLC fingerprint of the pilot-scale compound decoction of Huatan Jieyu Mixture.The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012)was used for similarity evaluation,and cluster analysis was performed.The contents of synephrine,paeoniflorin,hesperidin and solid substance in each sample were determined,and the transfer rates of the first three components were calculated.Results A total of 20 common peaks were marked in the HPLC chromatograms of 10 batches of compound decoction,and nine of them were identified,including synephrine,paeoniflorin,hesperidin and so on.The similarity of HPLC fingerprints of the compound decoction,concentrated decoction and centrifugate with the small-scale samples was 0.936,0.886 and 0.865,respectively.The cluster analysis showed that three batches of compound decoction and eight of ten batches of small-scale samples could be clustered into one group.The transfer rates of synephrine,paeoniflorin and hesperidin were 80.13%,51.36%and 9.97%respectively.The average content of solid substances in the compound decoction,concentrated decoction,centrifugate and pilot-scale products were 7.46,148.03,137.53 and 141.60 g/L,respectively.Conclusion The established method is fast,simple,feasible,repeatable and stable.It is suitable for the investigation of the quality value transmitting law of Huatan Jieyu Mixture pilot-scale compound decoction,concentrated decoction,centrifugate and pilot-scale products,and it can be used for the quality control of Huatan Jieyu Mixture.